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NCT06479668Completed

Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.

Source: ClinicalTrials.gov · Last updated 24 Aug 2026

Brief summary (registry, in English)

The aim of this protocol is to disentangle the links between symptoms of emotion dysregulation, sleep disorders and cognitive deficits by measuring the effects of an emotional induction task on childrens' sleep with autism spectrum disorders (ASD) and attention deficit hyperactivity disorder (ADHD).

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
21 Jun 2024
Start date
3 Oct 2024
Primary completion date
13 May 2026
Lead sponsor
University Hospital, Strasbourg, France
Diseases
Autism
NCT number
NCT06479668

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 3 Oct 2024 to the primary completion date, 13 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Transmeridian travel (\> 2 time zones) in the month prior to study inclusion
  • Modification of psychotropic medication in the 2 months prior to inclusion
  • Use of melatonin-based dietary supplement(s)/medication(s) in the 24 hours prior to study inclusion
  • Participation in research involving an experimental drug which may interfere with the protocol\*.
  • Subject in a period of exclusion (determined by a previous or current study)

Other illness

  • \- Current or past neurological problem(s) (e.g. stroke, epilepsy, meningitis, head trauma with loss of consciousness of more than 15 min, concussion, brain tumor, ...).
  • Presence of a mood disorder (bipolar disorder or depression) according to DSM-5 criteria
  • Cognitive-behavioral therapies (CBT) targeting sleep disorders

Other

  • tumor, ...)
  • Social jet-lag \> 2 hours (mid-point of sleep differential during weekends vs. weekdays)
  • Use of psychostimulant(s) within 48 hours of study entry
  • Extreme chronotype (Morningness/Eveningness questionnaire score \< 10 or \> 42)
  • Minor under guardianship
  • Subject in emergency situation

Who the study is looking for

  • Subjects aged 7 to 12
  • Able to receive clear, age-appropriate information and to participate fully in the study
  • Whose legal representative(s) are able to understand the objectives and risks of the research and to give their dated and signed informed consent.
  • Subjects benefiting from a social health insurance plan (beneficiary of the legal representative(s))
  • With a diagnosis made prior to inclusion of Autism Spectrum Disorder (ASD) or Attention Deficit Disorder with or without Hyperactivity (ADHD) as defined by Diagnostic and Statistical Manual 5 (DSM-5).
  • With abbreviated intelligence quotient \> 80 measured by Wechsler Intelligence Scale for Children version IV (WISC-IV )no more than 6 months prior to research inclusion
  • No diagnosis of: fragile X syndrome, Rett syndrome, trisomy 21, tuberous sclerosis of Bourneville, von Recklinghausen disease, Cytomegalovirus encephalitis (CMV encephalitis), congenital rubella, phenylketonuria
  • No clinically significant abnormality which, in the investigator's opinion, could interfere with the implementation of the study.

Age in the registry: 7 years to 12 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hopitaux Universitaires de Strasbourg
Coordinator of this site? Confirm its status
StrasbourgFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.